Regulatory Assistant

UNC-Chapel Hill • Chapel Hill, NC

12d • Hybrid

About The Position

The primary purpose of this position is to provide para-professional support within the Office of Clinical Translational Research collaborating with the Regulatory staff of the Lineberger Clinical Protocol Office. The Regulatory Assistant gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board ( IRB ) and research sponsors. This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. The Regulatory Assistant participates in the collection, compilation, and management of data/information. The Regulatory Assistant is responsible for quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. The Regulatory Assistant is expected to use considerable sound judgment and their effective research skills in performing their work assignments. Work may include the training and supervision of staff, students and others.

Requirements

• Working knowledge and facility with information technology, including Microsoft Outlook, Word, Excel, and PowerPoint
• ability to organize, record, and present information
• ability to lead exchange of information through dialog, instruction, and demonstration
• ability to develop working knowledge of regulatory requirements and procedures relating to essential document collection for oncology clinical research
• ability to communicate professionally both verbally and in writing

Nice To Haves

• Knowledge of regulatory policy relating to clinical research and institutional review boards

Responsibilities

• gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board ( IRB ) and research sponsors
• collection, compilation, and management of data/information
• quality assurance and quality control
• analysis by statistical or other means
• generation/production of new data/information
• editing and formatting of reports
• training and supervision of staff, students and others

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 11-50 employees